The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Chronic peripheral and splanchnic vasodilatation are the hallmark hemodynamic abnormality in cirrhosis and contribute to the pathogenesis of portal hypertension.

Alterations in intestinal motility and bacterial overgrowth in gut may predispose to the development of bacteraemia and endotoxaemia in cirrhotic patients which play a role in the hyperdynamic circulatory syndrome of cirrhosis. Probiotic therapy is aimed at changing the make-up of the indigenous microflora by administering specific strains of non-pathogenic and potentially beneficial microflora. In this study, the investigators hypothesize that a modification in the composition of the endogenous digestive microflora by oral bacteriotherapy with high potency probiotic preparations could be a safe way to regulate the portal pressure.

As there is a relative paucity in effective pharmacological treatment for portal hypertension, these novel and innovative therapy might provide important alternative or adjunct therapy to beta blockers in the clinical management of patients with portal hypertension.

Aims and objectives

To study in patients with cirrhosis and large varices whether probiotics and/or norfloxacin given for 2 months :

Consecutive patients of cirrhosis with portal hypertension who fulfill the following criteria:

Diagnosed cases of cirrhosis (by clinical, biochemical and radiological criteria with or without liver biopsy)

No history of upper GI bleeding in the past

Endoscopically documented large esophageal varices

Exclusion criteria

history of gastrointestinal bleeding

patients who have received beta blockers for portal hypertension in the past 6 weeks.

hepatic encephalopathy

ongoing bacterial infection,

Spontaneous bacterial peritonitis

active alcoholism or illicit drug abuse

alcoholic hepatitis

Treatment with antibiotics in the preceding 2 weeks.

presence of hepatocellular carcinoma,

portal vein thrombosis

serum creatinine>1.5 mg/dL,

treatment with vasoactive drugs in the past 6 weeks,

history of arterial hypertension, congestive heart failure or arterial occlusive disease, and

Refusal to participate.

Active smokers.

Study plan:

Ethical approval will be obtained prior to study initiation. Patients presenting to Department of Gastroenterology, GB Pant Hospital will be recruited in the study. Patients will be evaluated regarding the eligibility for the study. After being found eligible for the study, if the patient agrees to participate in the study, a signed informed consent will be obtained. Baseline HVPG will be measured in all patients and then they will be randomized into 3 groups:.

Group 1: Beta blockers + placebo

Group 2: Beta blockers + Norfloxacin (400mg BD)

Group 3: Beta blockers + probiotics. (one sachet of VSL#3 BD)

30 patients will be enrolled into each group. The treatment will be continued for 2 months.

The study design is a randomized double-blinded placebo controlled trial.

Once patients have been enrolled, they will undergo baseline investigations. Blood will be drawn from both peripheral and hepatic veins and sent for routine parameters, pro-inflammatory cytokines (IL-1b, IL-6, IL-10, TNF-α, endotoxins, NO2 and NO3 levels, PRA, BNP). Samples will be stored at -70 ºC. Baseline vitals will be recorded.

Patients will be called at the end of 1 month for assessment of compliance and then at the end of the study (2 months) to repeat the HVPG and the same parameters as at the time of enrollment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

12 Years to 75 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Consecutive patients of cirrhosis with portal hypertension who fulfill the following criteria:

Diagnosed cases of cirrhosis (by clinical, biochemical and radiological criteria with or without liver biopsy)

No history of upper GI bleeding in the past

Endoscopically documented large esophageal varices

Exclusion Criteria:

history of gastrointestinal bleeding

patients who have received beta blockers for portal hypertension in the past 6 weeks.

hepatic encephalopathy

ongoing bacterial infection,

Spontaneous bacterial peritonitis

active alcoholism or illicit drug abuse

alcoholic hepatitis

Treatment with antibiotics in the preceding 2 weeks.

presence of hepatocellular carcinoma,

portal vein thrombosis

serum creatinine>1.5 mg/dL,

treatment with vasoactive drugs in the past 6 weeks,

history of arterial hypertension, congestive heart failure or arterial occlusive disease, and

Refusal to participate.

Active smokers.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134692